Indications for HELIXATE FS:
Prevention and control of hemorrhagic episodes or in order to perform emergency or elective surgery in Hemophilia A patients.
Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse over 5–10minutes if tolerated. Minor hemorrhage: 10–20 IU/kg; may repeat dose if needed. Moderate/major hemorrhage or minor surgery: 15–30 IU/kg; may repeat 1 dose at 12–24hrs if needed. Major/life-threatening hemorrhage, fractures or head trauma: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: pre-op dose: 50 IU/kg (verify ~100% activity prior to surgery); may repeat after 6–12hrs initially, and for 10–14 days until completely healed.
HELIXATE FS Contraindications:
Mouse or hamster protein sensitivity.
HELIXATE FS Warnings/Precautions:
Not for treating von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C). Nursing mothers.
HELIXATE FS Classification:
Inj site reactions, dizziness, rash, dysgeusia, increased BP, pruritus, depersonalization, GI upset, rhinitis; antibody formation, hypersensitivity reactions.
Single-use bottle—1 (w. diluent)